OC responsibilities for biologics include reviewing the chemistry, manufacturing and controls section of submitted applications and the supplements with the Prescription Drug User Fee Act timelines, as well as conducting pre-license or pre-approval inspections required for licensure.
Because of the type of information required for approval of these products, OC is more actively engaged in formal meetings with sponsors or applicants regarding the development and review of the products in these human drug applications.
In all these types of inspections, OC is often in communication with FDA field investigators during the course of their inspections or investigations to clarify any concerns or questions that arise during the course of an inspection.